New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- visual acuity letter score
研究概览
简要总结
Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.
详细描述
Settings and Design: Randomized clinical study
Subjects and Methods:
investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •focal maculopathy
- •diffuse macular edema
- •diffuse macular edema with ischemic changes
排除标准
- •ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
- •patients with history of stroke or transient ischemic attack
- •hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- •uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
- •evidence of vitreomacular traction (in either eye)
- •active proliferative diabetic retinopathy (study eye)
结局指标
主要结局
visual acuity letter score
时间窗: one-year follow up
The visual acuity letter score at one-year
central subfield thickness (CST)
时间窗: one-year follow up
the mean CST observed at one-year
次要结局
- patient compliant-complications(one-year follow up)
研究者
khaled hamdi elbaklish
principal investigator
Ain Shams University